Therapeutic Evaluation of Alpha Lipoic Acid for Geographic Atrophy

We plan to enroll 50 adult patients with geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) into a randomized, double-masked, placebo-controlled Phase II trial. Subjects will be randomized (1:1) into one of two study arms: placebo capsules or ALA 1200 mg orally once daily. There will be three clinical sites, and the enrollment period is estimated to be 6 months. Study visits occur at baseline, and at 6, 12 and 18 months. Visits include a dilated fundus examination, visual acuity testing, fundus photography, fundus autofluorescence and optical coherence tomography (OCT). The primary endpoint is the mean rate of change of the area of GA in the study eye from baseline to 18 months as evaluated by fundus autofluorescence. The secondary endpoints include: the change in best corrected visual acuity (BCVA) from baseline to 18 months, rate of change of GA area on color photos, the proportion of patients with three lines or worsening in BCVA and ocular and systemic safety outcomes for this dose of ALA. Before proceeding with this Phase II study, we will confirm the tolerability of this dose of ALA in the elderly population with a Phase I study.